Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL)
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Purpose
The goal of this clinical research study is to learn if ofatumumab can help to control CLL. The safety of this drug will also be studied.
Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the leukemia cells to die.
Objectives:
Primary Objective:
1. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with CLL.
Secondary Objective:
- To determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients.
- To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL.
- To determine the plasma levels of ofatumumab in elderly, unfit patients.
- To evaluate predictive capability of miRNAs detection in plasma samples
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers Leukemia |
Drug: Ofatumumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL) |
- Overall Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of participants with Overall Response (OR) which equals Complete and Partial Responses (CR+PR) divided by total number of participants. Response assessed after month 3, month 6 and every 6 months thereafter using the 2008 National Cancer Institute (NCI) Working Group criteria for response.
| Estimated Enrollment: | 34 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ofatumumab
Four weekly intravenous infusions at 300 mg during week 1, then 2,000 mg weeks 2, 3 and 4, then monthly during months 2-12.
|
Drug: Ofatumumab
Starting dose: 300 mg by vein during week 1, then 2000 mg in weeks 2, 3 and 4, then monthly during months 2-12.
Other Name: Arzerra
|
Detailed Description:
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ofatumumab by vein every week for 4 weeks. After that, you will receive it every month. Each infusion will last about 4 hours.
Before you receive ofatumumab, you will be given drugs to help reduce the risk of side effects.
- You will take Tylenol (acetaminophen) by mouth.
- You will receive diphenhydramine by vein over about 5 minutes.
- You will receive a steroid by vein over about 5 minutes.
- You will take allopurinol by mouth during the first 14 days of treatment.
Study Visits:
Every other week, blood (about 1 teaspoon) will be drawn for routine tests.
Every month, you will have a physical exam. If your doctor thinks it is needed, you will also have a bone marrow biopsy to check the status of the disease.
After Month 6 and every 6 months after that, you will have a bone marrow biopsy and aspiration to check the status of the disease.
Length of Treatment:
You may continue receive the study drug for up to 12 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Ofatumumab is FDA approved for the treatment of chronic lymphocytic leukemia that has relapsed. Its use in this study for initial treatment of CLL is investigational.
Up to 34 patients will take part in this study. All will be enrolled at MD Anderson.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.
- ECOG/WHO performance status of 2-3.or patients with chronic lymphocytic leukemia requiring treatment age >65 years at the time of signing informed consent and ECOG/WHO performance status of 0-1 and a CIRS or Charlson co-morbidity score of 2 or higher.
- Adequate renal and hepatic function (creatinine <2mg/dL and eGFR more than 30cc/minute, bilirubin <2mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. Patients with Gilbert's syndrome are eligible.
Exclusion Criteria:
- Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
- Known positivity for HIV.
- Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
- Prior treatment for chronic lymphocytic leukemia.
- Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
- Any known hypersensitivity to ofatumumab or its components.
Contacts and Locations| Contact: Alessandra Ferrajoli, MD, BS | 713-792-2063 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Alessandra Ferrajoli, MD,BS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01444716 History of Changes |
| Other Study ID Numbers: | 2011-0520, 15857, NCCN-006 |
| Study First Received: | September 28, 2011 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancers Leukemia Chronic Lymphocytic Leukemia CLL |
Elderly Ofatumumab Arzerra |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms Neoplasms by Histologic Type |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013